Biofreeze Professional

Product NDC: 68071-4325
11-digit product format: 680714325
Labeler code: 68071
Product ID: 68071-4325_1a3dd23e-1c5a-9d41-e063-6394a90a3455
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, UNSPECIFIED FORM
Dosage form: GEL
Route: TOPICAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-06-03
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 50 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-4325-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-4325-4	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4325-4	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Biofreeze Professional
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
415975	Internal RxNorm lookup
1794892	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
66ff9726-20da-688a-e053-2a91aa0a59ac	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-07	Biofreeze Professional Gel
2023-01-30	Biofreeze Professional Gel
2021-02-16	Biofreeze Professional Gel
2021-01-29	Biofreeze Professional Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4325-4	Biofreeze Professional	120 mL in 1 TUBE	GEL	120		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4325	BIOFREEZE PROFESSIONAL (MENTHOL, UNSPECIFIED FORM) GEL [NUCARE PHARMACEUTICALS,INC.]	6	Current NDC, Legacy NDC, 1 package rows	20240608_66ff9726-20da-688a-e053-2a91aa0a59ac.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 15 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neosporin Kids Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	6752f0a0-2432-4d8b-8198-74ae96a68963	2024-11-13	Warnings	Exact identifier application number: M004
Neosporin Original	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Kenvue Brands LLC	a3e6fe2e-1b74-4f22-9c7c-a00057439690	2024-11-13	Warnings	Exact identifier application number: M004
Neosporin Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	32302dcd-f3f1-408b-ae5f-e7d8b666f68f	2024-11-13	Warnings	Exact identifier application number: M004
NEOSPORIN Plus BURN RELIEF	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	3caa7fd1-bd66-427e-a6c0-1b137b205089	2024-11-13	Warnings	Exact identifier application number: M004
Simply Neosporin First Aid Antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Kenvue Brands LLC	68bfecea-095f-4d3f-b077-d86e1b9f1faa	2024-11-13	Warnings	Exact identifier application number: M004
Triple Antibiotic and Burn Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	CVS Pharmacy	fdc510b8-f3ad-4bd6-a8d0-1b81e9f30e13	2024-11-13	Warnings	Exact identifier application number: M004
BACITRACIN	BACITRACIN	ALLIED TRADE LINK LLC	253e5b98-c64f-3226-e063-6294a90a9352	2024-11-12	Warnings	Exact identifier application number: M004
TRIPLET ANTIBIOTIC	TRIPLET ANTIBIOTIC	ALLIED TRADE LINK LLC	26bd5ba4-264b-2a28-e063-6394a90ada80	2024-11-12	Warnings	Exact identifier application number: M004
basic care first aid antibiotic and burn relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	Amazon.com Services LLC	0df4c44d-6912-4db9-a703-a82da4c8ae76	2024-11-11	Warnings	Exact identifier application number: M004
SUPER SENSITIVE HAND SANITIZER	ALCOHOL	ORGANIC & SUSTAINABLE BEAUTY	7d4a5b21-82d2-4904-9577-4a9b2579076e	2024-11-08	Warnings	Exact identifier application number: M004
dg health triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Dolgencorp, LLC	4c97dada-966f-4de8-b5d9-e939cb456aea	2024-11-06	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	A-S Medication Solutions	de07139e-ece9-424b-8468-f5ed4bbb2b2b	2024-11-06	Warnings	Exact identifier application number: M004
good sense triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	L. Perrigo Company	e9e913d8-8ec8-4465-ad3a-b524f6710a0f	2024-11-06	Warnings	Exact identifier application number: M004
EUCALYPTUS EASE HAND SANITIZER	ALCOHOL	ORGANIC & SUSTAINABLE BEAUTY	09d77591-9472-4771-9090-3390bddf788a	2024-11-06	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	A-S Medication Solutions	e115d413-e41c-4e43-8184-493d64dfcd9f	2024-11-06	Warnings	Exact identifier application number: M004
LEMON MYRTLE HAND SANITIZER	ALCOHOL	ORGANIC & SUSTAINABLE BEAUTY	f341b24c-9466-42f4-98fe-d1a122591915	2024-11-06	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	A-S Medication Solutions	00747e3a-389c-46bc-b6b9-9b3d1d98dbcf	2024-11-06	Warnings	Exact identifier application number: M004
Signature Care Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Safeway	46db4b66-85a2-47fc-a643-df6477e2ddff	2024-11-06	Warnings	Exact identifier application number: M004
CALMING HAND SANITIZER	ALCOHOL	ORGANIC & SUSTAINABLE BEAUTY	ffcbe34d-3c53-47f9-9e4a-b5448afbbd5d	2024-11-05	Warnings	Exact identifier application number: M004
Antibiotic, Pain and Scar	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	CVS Pharmacy	8bb6cb64-103f-454a-95ad-c2c56b9cf71a	2024-11-05	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1794892	BIOFREEZE 5 % Topical Gel	PSN	66ff9726-20da-688a-e053-2a91aa0a59ac	6
415975	menthol 5 % Topical Gel	PSN	66ff9726-20da-688a-e053-2a91aa0a59ac	6
1794892	menthol 0.05 MG/MG Topical Gel [Biofreeze]	SBD	66ff9726-20da-688a-e053-2a91aa0a59ac	6
415975	menthol 0.05 MG/MG Topical Gel	SCD	66ff9726-20da-688a-e053-2a91aa0a59ac	6
1794892	Biofreeze 5 % Topical Gel	SY	66ff9726-20da-688a-e053-2a91aa0a59ac	6
415975	menthol 5 % Topical Gel	SY	66ff9726-20da-688a-e053-2a91aa0a59ac	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4325-4	68071432504	120 mL in 1 TUBE (68071-4325-4)	120 ml	2018-03-09	0000-00-00	No	No	Current